Study on the Safety and Effectiveness of SpectraCure P18 System and Verteporfin for Treating Recurrent Prostate Cancer

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What is this study about?

This clinical trial is focused on studying the treatment of recurrent prostate cancer. The treatment being tested involves the use of a special system called the SpectraCure P18 System, which includes multiple diode lasers and a software called IDOSE®. Additionally, a medication known as verteporfin for injection (VFI) is used. The purpose of the study is to assess the safety and effectiveness of this treatment combination for patients with prostate cancer that has returned after initial treatment.

Participants in the study will receive the treatment, which involves the use of the SpectraCure P18 System to deliver light directly to the cancer cells. This is done to help eliminate the cancer cells in the prostate. The study will also determine the safest and most effective doses of both the drug and the light used in the treatment. The treatment is administered through a process called infusion, where the medication is delivered directly into the bloodstream.

The study will monitor participants over a period of time to evaluate the treatment’s impact on the cancer and any side effects that may occur. The effectiveness of the treatment will be assessed using imaging techniques like MRI to see how well the cancer responds. The goal is to find out if this new approach can safely and effectively treat recurrent prostate cancer, providing a potential new option for patients facing this condition.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. You will be required to sign an informed consent form, which confirms your understanding and agreement to participate in the trial.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and conducting necessary tests to ensure you meet the study criteria.

3 treatment planning

A treatment plan will be developed using the SpectraCure P18 System, which involves interstitial multiple diode lasers and IDOSE® software. The system will calculate the required light dose for treating the recurrent prostate cancer.

4 medication administration

You will receive an injection of verteporfin for injection (VFI), which is part of the treatment process. The dosage and frequency will be determined by the study team based on your specific needs.

5 light treatment

The SpectraCure P18 System will be used to deliver the calculated light dose to the prostate cancer cells. This process is designed to eliminate cancer cells effectively.

6 monitoring and follow-up

After the treatment, you will be monitored for any side effects or adverse reactions. Follow-up visits will be scheduled to assess the treatment’s effectiveness and your overall health.

7 final evaluation

A final evaluation will be conducted to determine the success of the treatment. This may include imaging tests and biopsies to check for the presence of cancer cells.

Who Can Join the Study?

Men over 18 years old who have had radiation therapy for prostate cancer and have a confirmed return of the cancer in the prostate.
For Phase 1: The area of cancer to be treated should be less than 50 cubic centimeters, as measured by a special ultrasound.
For Phase 2: The area of cancer to be treated should be less than 50 cubic centimeters.
For Phase 1: Patients should not be eligible for surgery or further radiation therapy aimed at curing the cancer.
For both phases: Patients should have a performance status of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
For Phase 1: Patients should have an expected survival of at least 8 months.
For Phase 2: Patients should have an expected survival of at least 12 months.
For both phases: Patients should have enough healthy bone marrow, shown by a granulocyte count of at least 1500 per cubic millimeter and a platelet count of at least 100,000 per cubic millimeter. Granulocytes and platelets are types of blood cells important for fighting infection and stopping bleeding.
For both phases: Patients should have good kidney function, shown by a creatinine level of 1.5 milligrams per deciliter or less. Creatinine is a waste product in the blood that comes from muscles.
For both phases: Patients should have good liver function, shown by a total bilirubin level of 1.5 milligrams per deciliter or less, and liver enzymes (SGOT and ALT) that are no more than three times the normal upper limit. Bilirubin is a substance made during the normal breakdown of red blood cells, and SGOT and ALT are enzymes that help measure liver health.
For both phases: Patients must sign an Informed Consent form, which means they agree to participate in the study after being told about the risks and benefits.

Who Cannot Join the Study?

Patients who do not have recurrent prostate cancer cannot participate. This means the cancer must have returned after initial treatment.
Only male patients are eligible to participate in this study.
Patients who are part of a vulnerable population are not eligible. This typically includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Staedtisches Klinikum Braunschweig gGmbH	Brunswick	Germany
Region Skane Skanes Universitetssjukhus	Lund	Sweden

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	01.03.2023
Sweden	Recruiting	01.03.2023

Trial locations

Investigated drugs:

Ciprofloxacin

The SpectraCure P18 System is a medical device used in this clinical trial. It consists of multiple diode lasers and special software called IDOSE®. This system is designed to treat recurrent prostate cancer by delivering light directly to the cancer cells. The goal is to eliminate these cells by calculating and controlling the right amount of light needed. The system also helps in positioning the fibers accurately to ensure the light reaches the cancer cells effectively.

Verteporfin for injection (VFI) is a medication used in this trial. It is a drug that becomes active when exposed to light, a process known as photodynamic therapy. In this study, verteporfin is injected into the body and then activated by the light from the SpectraCure P18 System. This combination aims to destroy the cancer cells in the prostate by using the light to activate the drug, which then works to kill the cancer cells.

Investigated diseases:

Prostate cancer recurrent

Recurrent prostate cancer – Recurrent prostate cancer refers to the return of cancer in the prostate gland after initial treatment. This disease can manifest locally within the prostate or spread to other parts of the body. The progression of recurrent prostate cancer can vary, with some cases showing slow growth while others may advance more rapidly. Symptoms may include difficulty urinating, pelvic pain, or blood in the urine, although some individuals may not experience noticeable symptoms. The disease is often monitored through prostate-specific antigen (PSA) levels, which can indicate cancer activity. As the cancer progresses, it may affect surrounding tissues and organs, potentially leading to further complications.

Trial ID:

2022-502285-24-00

Protocol code:

SPC11-01-110

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety and Effectiveness of SpectraCure P18 System and Verteporfin for Treating Recurrent Prostate Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?